ANNEX: DIAGNOSTIC PRODUCT SUPPORT AND MARKETING COSTS ENCOUNTERED IN LOWER AND MIDDLE INCOME COUNTRIES

In certain markets, the manufacturer may need to be involved in assisting the development of ancillary activities necessary to enable use and scaling of the product. In such cases, the commercialisation strategy may prioritize other markets where costs of entry are lower, or the CP may include an overview of costs and timescale to put such activities in place e.g.:

✓ Logistics (getting tests to users)

Identifying appropriate supply lines: Appropriate environmental management, replenishment frequency, and security. ✓ Training, training materials and job-aids (ensuring tests are used correctly)

Development of (where possible, adaption of existing) evidence-based training materials and job-aids.

Testing of training materials and job-aids on a representative set of intended users – including translation and testing for different linguistic groups, can add signifciant cost. Examples exist that can form a basis for adaption and facilitate this process, e.g.: https://www.finddx.org/implementation-resources/ ✓ Educational and marketing materials

Identification of key messages that will address knowledge gaps or beliefs in the population that could restrict access or interest in appropriate testing. This may require formal studies of health-seeking behavior and beliefs and is a specialist activity normally carried out by research institutions. ✓ Data management and reporting

Development of connectivity and compatibility with existing and anticipated data management systems.

Easing the burden on the health provider of monitoring and planning may lower the threshold for market entry. Standards and guidance on this area, which is of increasing importance to new product integration, are being developed by WHO, e.g.: https://apps.who.int/iris/bitstream/handle/10665/260480/

WHO-RHR-18.06-eng.pdf?sequence=1

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October 2019

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